Sungura Study
Efficacy, safety and tolerability of switching to DTG/3TC single tablet regimen from B/F/TAF in older persons living with HIV in Kenya.
Duration
96 weeks
Participants
197 adults
Age criteria
≥ 60 years
Phase 3b, multi-center, open-label, single arm clinical trial over 96 weeks to assess the efficacy and safety of switching to dolutegravir and lamivudine (DTG/3TC) single tablet regimen from bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) in 197 adults aged 60 years and older living with HIV in Kenya.
Primary Endpoint
Proportion of participants with HIV-1 RNA <50 copies/mL at Week 48
Assess the efficacy of switching from B/F/TAF to DTG/3TC in maintaining viral suppression
Evaluate the safety and tolerability of DTG/3TC in older adults living with HIV
Monitor changes in renal and bone biomarkers following the switch
Assess patient-reported outcomes and quality of life measures
Evaluate treatment satisfaction and adherence to the new regimen
Inclusion
HIV-1 positive adults aged 60 years or older
Currently receiving B/F/TAF (bictegravir, emtricitabine and tenofovir alafenamide)
Virologically suppressed (HIV-1 RNA <50 copies/mL for at least 6 months)
No documented resistance mutations to study drugs
Stable on current regimen for at least 3 months
Able to provide informed consent
Exclusion
Known hypersensitivity to dolutegravir or lamivudine
Active opportunistic infections
Severe hepatic impairment
Concurrent use of medications with significant drug interactions
Pregnant or breastfeeding women
History of non-adherence to antiretroviral therapy
Screening visit with comprehensive medical history and physical examination
Laboratory assessments including HIV-1 RNA, CD4+ cell count, and safety parameters
Switch to DTG/3TC single tablet regimen
Regular follow-up visits at weeks 4, 12, 24, 48, 72, and 96
Adverse event monitoring and safety assessments
Patient-reported outcome questionnaires
End-of-study evaluations